Navi CEO Alex Newton and Chief Medical Officer A/prof Christiane Theda sat down with the team from the LiSTNR podcast “Beyond The Medicine Cabinet”, where they covered the story of Sarah and James, whose son Archie spent 210 days in the NICU. They also discussed Navi’s current innovation, the Neonav ECG Tip Location System, and the importance of giving every child the best start from day one.
You can listen to the entire podcast below, or scroll down to read highlights from the discussion:
Some highlights from the podcast include:
Due to complications during pregnancy, Sarah and James’s son Archie was born premature at 26 week gestation, weighing just over 500 grams.
Just after birth, little Archie was rushed away to the Neonatal Intensive Care Unit (NICU), where he would receive numerous procedures and surgeries, including Central Vascular Catheters, or CVC’s and ultimately stay for 210 days.
CVC’s deliver life saving medications, nutrition and fluids to premature newborns like Archie.
The position and location of CVC’s inside the patient is important. If the catheter ends up in an area that is deemed unsafe, such as deep inside the heart or liver, this can cause significant complications and harm if left undetected.
Stephanie Pitts, who is a Vascular Access Nurse based in Florida, USA, explained CVC’s and the challenges using them in premature newborns in more detail
“Infants and neonates are not small adults. They have distinct key physiological differences between babies and adults … They are much more difficult when it comes to vascular access procedures because of their [smaller] size vessel size and complexity.”
Pictured: Premature newborn in the Neonatal Intensive Care Unit (NICU)
Navi co-founder and CEO Alex Newton explained the solution he and the Navi team are working on,
“What we are building is a medical device called an ECG Tip Location System that essentially listens to the electrical activity of the heart through the catheter, and by analysing the signal we are actually able to provide real time positioning data back to the doctors and nurses … we can tell them if [the catheter] is in a safe location, or if it is still in a safe location”.
The Neonav device will not only help make the insertion procedures quick and easy for the doctors and nurses, but more importantly improve patient safety and reduce complications associated with incorrectly positioned catheters.
A/Professor Christiane Theda, who is a senior neonatologist and Navi Chief Medical Officer, understands all too well the challenges doctors face regarding central line positioning, explaining the issue relating to catheter migration:
“Sometimes the catheters once they are in the right spot still actually move a little bit, and we call that a migration event. With the Neonav [ECG Tip Location System] we offer a method to check on that migration fairly quickly and easily without disturbing the baby much … so this way we can contribute to the patients safety to make sure the catheters stay in a safe location,”
Gillian Foo, a Neonatal fellow in Melbourne uses this technology currently in a clinical study, and thinks it is an easy and practical technology to use bedside:
“Essentially, it’s a very easy technology to use. [The Neonav algorithm] tells you if there is a red bit that’s too high, means you’re in too far too close to the heart. If there is no red bit and no wave, then you’re not deep enough and you need tp push that catheter in deeper.”
Navi CEO Alex Newton highlights the current gap regarding available medical devices available specifically for newborns
“The data from the FDA shows that only 5% of medical devices that are approved in the US market actually have an indication for use in newborn patients. So when you talk to specialists in the neonatal or pediatric domain, it’s a common frustration to say that they just cant find the right size products some time.”
Animation example of a central line migration event occurring in the liver (left) and the heart (right)
Memorable quotes:
“It was horrific … we had to make the decision whether they would revive him or not, which was traumatic … I remember he was so tiny, the size of James’s hand … [he had] all these tubes and wires everywhere.” - Sarah (Archie’s mother)
“Just having a small improvement in that [of a persons life] could grow into a huge amount of impact into that persons life…. so for us, one of the areas we wanted to look at was to try and have a positive influence on somebodies life as early as possible” - Alex Newton, CEO of Navi Medical Technologies
“When he was first born he had the [umbilical] line through his umbilical chord access point. And then when he was about 2 weeks old he got his first PICC line, which he was only about 500 grams then … we just know how precious [the central lines] are as they are the only access point for his food and medication … essentially keeping him alive …” - Sarah (Archie’s mother)